ST Segment Elevation Myocardial Infarction, Primary Percutaneous Coronary Intervention
Conditions
Keywords
Prevention, Slow flow, No reflow, Nitroprusside, Tirofiban
Brief summary
Primary percutaneous coronary intervention (PPCI) is the gold standard of treatment of ST segment elevation myocardial infarction (STEMI).Slow flow / no-reflow phenomenon following PPCI in STEMI patients has been a serious and common complication that closely related to the incidence of major adverse cardiovascular events (MACE) and affected patients' prognosis. No reflow is a multi-factorial phenomenon. And its preventive and therapeutic effects are not satisfactory. This prospective randomized controlled study aimed to compare favorable effects of Nitroprusside versus Tirofiban on the prevention of slow flow / no-reflow phenomenon during PPCI.
Interventions
Intracoronary infusion 50\ 100μg each time (repeated)
Intracoronary infusion 10μg/kg for single time
Intracoronary infusion 2ml for single time
Sponsors
Anyang Regional Hospital
Huaihe Hospital of Henan University
The First Affiliated Hospital of Henan University of Science and Technology
Yellow River Sanmenxia hospital
The Peoples' Hospital of Jiaozuo City
Jincheng People's Hospital
The second people's Hospital of Jiyuan
Kaifeng Central Hospital
Lushan People's Hospital
Nanyang Central Hospital
The Second People's Hospital of Pingdingshan
Shenma Medical Group General Hospital
Puyang People's Hospital
Puyang Oilfield General Hospital
The First People's Hospital of Shangqiu
Yanshi People's Hospital
The First People's Hospital of Xinmi
First Affiliated Hospital of Xinjiang Medical University
Xinyang Central Hospital
People's Hospital of Zhengzhou University
Zhengzhou First People's Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Zhengzhou Central Hospital
The 99th Central Hospital of the People's Liberation Army
Zhoukou Central Hospital
The First People's Hospital of Zhumadian
Zhumadian Central Hospital
The First Affiliated Hospital of Zhengzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ischemic symptoms \< 12h, or evidence of ongoing ischemia 12h after symptom onset * Continued ischemic chest pain \> 30min * ST-segment elevation ≥ 0.1 millivolt in 2 or more contiguous leads on the 12-lead ECG or new left bundle branch block (LBBB) * Detection of a rise of cardiac biomarker values with at least one value above the 99th percentile upper reference limit (URL) * Primary coronary artery angiography was planned.
Exclusion criteria
* Emergency thrombolytic therapy was performed before primary coronary artery angiography * Cardiogenic shock with no response to hypervolemic treatment or vasopressor * Severe cardiomyopathy or valvular disease requiring intervention * Coronary ectasia * Severe heart failure * Contraindication or allergy to antiplatelet drugs * Contraindication or allergy to experimental drugs * Unable to receive at least 1 year of dual antiplatelet therapy * Active bleeding or extreme-risk for major bleeding * Severe liver or renal failure * Life expectancy \< 1 year * Unable or unwilling to provide informed consent * Women of child bearing potential * Under 18 years of age * Hemoglobin \< 90g/L * Platelet count \< 100×10\^9/L * Can not cooperate (with mental disorders or cognitive disorders)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ECG ST-segment fall more than 50% | in 2 hours post-PCI | The extent of ST segment elevation was reduced by more than 50% |
| Coronary artery flow using thrombolysis in myocardial infarction (TIMI) flow grade after stent implantation | 1 minute after stent implantation | Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery. |
| Coronary artery flow using TIMI flow grade after balloon dilatation | 1 minute after balloon dilatation | Grade 0, no myocardial blush or contrast density; grade 1, minimal myocardial blush or contrast density; grade 2, moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery; grade 3, normal myocardial blush or contrast density comparable with that obtained during angiography of a contralateral or ipsilateral noninfarct-related coronary artery. |
| Coronary TIMI frame count after stent implantation | 1 minute after stent implantation | A continuous measurement assessing flow in the epicardial arteries. |
| Coronary TIMI frame count after balloon dilatation | 1 minute after balloon dilatation | A continuous measurement assessing flow in the epicardial arteries. |
| Slow flow / no-reflow phenomenon after stent implantation | 1 minute after stent implantation | Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree. |
| Slow flow / no-reflow phenomenon after balloon dilatation | 1 minute after balloon dilatation | Slow flow phenomenon means delayed progression or lack of contrast medium through the coronary tree. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Main adverse cardiovascular and cerebrovascular events (MACCE) | at 1 day post-PCI, at follow up of 1, 3, 6,12 months post-PCI | Death, Cardiac death, Rehospitalization (Heart failure) , Non-fatal myocardial infarction, Target vessel myocardial infarction, Target lesion revascularization, Target vessel revascularization, Ischemic-driven revascularization, Stent thrombosis, Bleeding, Cerebrovascular events, etc. |
Countries
China
Contacts
Primary ContactChunguang Qiu, Phd
Backup ContactLiang Pan, MD
Outcome results
None listed